BA strategic leader and expert in all aspects of Pharmaceutical CMC and QA. Technically and managerially extremely competent, with over 35 years relevant experience; I have lead Quality Operations under every type of pharmaceutical manufacturing and wholesale licenses, expert in all dosage forms. Additionally, nine years as consultant / interim manager has given a unique perspective and flexibility for a pharmaceutical professional, able to adapt extremely quickly to any work environment and make changes as required in a fully collaborative manner.
Skills include:
- Over 35 years of relevant experience, more than 20 of which in senior QA / CMC roles.
- Have been named as QP on several highly complex manufacturing sites. Biologics + ATMPs, also small molecules.
- Named as Designated Individual for ATMP manufacturer / clinical trial sponsor.
- Named as RP on several wholesale licenses in UK and Ireland.
- QA/QP lead on multiple cutting edge, biologics clinical products.
- Directly lead multiple departments, including, Regulatory Affairs, Quality Control, Product Development, Operational QA (GMP, GCP, PV, GDP), QA systems, Validation.
- I have lead operations within small Biotechs through to Multi-nationals. Managing teams from 8 to 90 professionals, accountable for multi-million budgets.
- Successful pharmaceutical Infrastructure buildout (UK and RoW) – QMS construction/updates, facilities/equipment procurement and validation, license (MS, MIA, IMP, WDA) applications and approvals.
- Successfully hosted over 60 Regulatory Agency inspections (GDP and GMP) from all major competant authorities (FDA, multiple EU authorities, ANVISA, WHO).
- Post-graduate Pharmaceutical specific education leading to internationally recognized positions of Qualified Person, Responsible Person, Designated Individual.
- Conducted over 150 vendor audits (as lead auditor)
